Drugs
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Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) Information
Commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget's disease. Osteoporosis is a disease that makes bones weak and more likely to break.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.
To report any serious adverse events associated with the use of these drugs, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.
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Related Information
FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)
9/1/2011FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer
7/21/2011FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
(10/13/2010)FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures
(3/10/2010)Information for Healthcare Professionals: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)
FDA ALERT (1/7/2008)Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates
(11/12/2008)Early Communication of an Ongoing Safety Review on Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)
(10/1/2007)Severe Pain with Osteoporosis Drugs
FDA Patient Safety News (3/2008)
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Labeling and Regulatory History from Drugs@FDA
Alendronate Sodium (marketed as Fosamax) Prescribing and Labeling Information Etidronate Disodium (marketed as Didronel) Prescribing and Labeling Information Ibandronate Sodium (marketed as Boniva) Prescribing and Labeling Information Pamidronate Disodium (marketed as Aredia) Prescribing and Labeling Information Risedronate Sodium (marketed as Actonel) Prescribing and Labeling Information Tiludronate Disodium (marketed as Skelid) Prescribing and Labeling Information Zoledronic Acid (marketed as Reclast) Prescribing and Labeling Information Zoledronic Acid (marketed as Zometa) Prescribing and Labeling Information
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Risk Evaluation and Mitigation Strategies (REMS) Letters
(Issued 10/13/2010)
- Actonel REMS Letter (PDF - 95KB)
Actonel with Calcium REMS Letter (PDF - 83KB)Atelvia REMS Letter (PDF - 92KB)Boniva (Injection) REMS Letter (PDF - 83KB)Boniva (Tablets) REMS Letter (PDF - 91KB)- Fosamax REMS Letter (PDF - 82KB)
Fosamax Plus D REMS Letter (PDF - 91KB)Reclast REMS Letter (PDF - 92KB)
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